Progression-free survival as determined by Kaplan-Meier method.
| Group | Value | 95% CI |
|---|---|---|
| Temozolomide | 35.7 |
| Group | Value | 95% CI |
|---|---|---|
| Temozolomide | 27.3 |
| Group | Value | 95% CI |
|---|---|---|
| Temozolomide | 7.4 |
| Group | Value | 95% CI |
|---|---|---|
| Temozolomide | 35.7 |
Last reviewed · How we verify
The Effects of Continuous 28-day (28/28) Temozolomide Chemotherapy in Subjects With Recurrent Malignant Glioma Who Have Failed the Conventional 5-day (5/28) Treatment (P04601)
Phase 2 trial testing Temozolomide in Glioma in 120 participants. Completed in 15 September 2009.
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 9 June 2006 |
| Primary completion | 15 September 2009 |
| Estimated completion | 15 September 2009 |
Merck Sharp & Dohme LLC — full company profile →
Adults 19 to 70, any sex, with Glioma or Astrocytoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free survival as determined by Kaplan-Meier method.
| Group | Value | 95% CI |
|---|---|---|
| Temozolomide | 35.7 |
| Group | Value | 95% CI |
|---|---|---|
| Temozolomide | 27.3 |
| Group | Value | 95% CI |
|---|---|---|
| Temozolomide | 7.4 |
| Group | Value | 95% CI |
|---|---|---|
| Temozolomide | 35.7 |
Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Temozolomide |
|---|---|---|
| CONVULSION | Nervous system disorders | — |
| CONFUSIONAL STATE | Psychiatric disorders | — |
| GENERAL PHYSICAL HEALTH DETERIORATION | General disorders | — |
| PAIN | General disorders | — |
| APHASIA | Nervous system disorders | — |
| HEADACHE | Nervous system disorders | — |
| LEUKOPENIA | Blood and lymphatic system disorders | — |
| NEUTROPENIA | Blood and lymphatic system disorders | — |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | — |
| MYOCARDIAL INFARCTION | Cardiac disorders | — |
| NAUSEA | Gastrointestinal disorders | — |
| PANCREATITIS | Gastrointestinal disorders | — |
| VOMITING | Gastrointestinal disorders | — |
| ASTHENIA | General disorders | — |
| IRRITABILITY | General disorders | — |
| HERPES ZOSTER | Infections and infestations | — |
| CONTUSION | Injury, poisoning and procedural complications | — |
| HEPATIC ENZYME INCREASED | Investigations | — |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | — |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | — |
| NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| TUMOUR HAEMORRHAGE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| ATAXIA | Nervous system disorders | — |
| BALANCE DISORDER | Nervous system disorders | — |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | — |
| Reaction | System | Temozolomide |
|---|---|---|
| FATIGUE | General disorders | — |
| NAUSEA | Gastrointestinal disorders | — |
| HEADACHE | Nervous system disorders | — |
| VOMITING | Gastrointestinal disorders | — |
| HEMIPARESIS | Nervous system disorders | — |
| MEMORY IMPAIRMENT | Nervous system disorders | — |
| CONVULSION | Nervous system disorders | — |
| CONSTIPATION | Gastrointestinal disorders | — |
| COUGH | Respiratory, thoracic and mediastinal disorders | — |
| GAIT DISTURBANCE | General disorders | — |
| CONFUSIONAL STATE | Psychiatric disorders | — |
| INSOMNIA | Psychiatric disorders | — |
| MONOPARESIS | Nervous system disorders | — |
| ORAL CANDIDIASIS | Infections and infestations | — |
| SOMNOLENCE | Nervous system disorders | — |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | — |
| RASH | Skin and subcutaneous tissue disorders | — |
| OEDEMA PERIPHERAL | General disorders | — |
| BALANCE DISORDER | Nervous system disorders | — |
| DIARRHOEA | Gastrointestinal disorders | — |
| ASTHENIA | General disorders | — |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | — |
| DIZZINESS | Nervous system disorders | — |
| HEMIANOPIA | Nervous system disorders | — |
| NEUTROPENIA | Blood and lymphatic system disorders | — |
| VISION BLURRED | Eye disorders | — |
| DYSPEPSIA | Gastrointestinal disorders | — |
| OEDEMA | General disorders | — |
| HYPOAESTHESIA | Nervous system disorders | — |
| SPEECH DISORDER | Nervous system disorders | — |
Most-reported serious reactions: CONVULSION, CONFUSIONAL STATE, GENERAL PHYSICAL HEALTH DETERIORATION, PAIN, APHASIA, HEADACHE, LEUKOPENIA, NEUTROPENIA.
Data from ClinicalTrials.gov NCT00392171 adverse events section.
The purpose of this non-randomized, open-label, multicenter, Phase II, 2-stage design, RESCUE study is to test the hypothesis that continuous 28-day oral dosing (28/28) with dose-intense temozolomide (50 mg/m\^2) for up to 12 months may overcome resistance and be effective in the management of adult patients with malignant glioma who have failed following at least 2 cycles (2 months) of conventional 5-day (5/28) cycles of high-dose temozolomide (150-200 mg/m\^2).
2 peer-reviewed publications reference this trial (live from Europe PMC):
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